1. Field of the Invention
This invention relates to localizing devices and more particularly to localizing devices that use external markers to assist in localization. This invention relates to stabilizing devices to control compliant and/or elastic structures. This invention has particular usefulness in-medical and industrial applications.
2. Description of the Prior Art
Presently available localization devices use a grid apparatus which is firm and inflexible and indicates lesion or structure location information in only one plane requiring repositioning to obtain location information in any other plane. Other available localization devices and procedures use uncontrollable and variably reliable methods to attempt to induce accuracy such as vision, touch, consistency, assumption of position, and are used singly or in combination. These methods produce highly variable results with respect to accuracy. This results in repeat of biopsy, and exposes the patient to other medical problems such as excessive trauma to the structure, infection, excessive bleeding, excessive exposure to radiation, pneumothorax and others.
Localization devices have long been used in locating lesions or other area of interest within human parts. These consist of flat, firm plate-like material with calibrated markings and permeations fixed to a firm metallic control arm which compresses subject human body part against a firm plastic or metallic x-ray cassette held in place by a metallic cassette holding table. X-rays are taken to determine the relationship of the localizing device to the lesion or other area of interest within human body parts. A localizing device, such as a needle, is placed through the permeated grid into or near the lesion or other area of interest within human body parts and this placement is determined and guided by the relationship of the grid to the location of the lesion or other area of interest within the human body part. Another x-ray is obtained to determine accuracy of placement of the localizing device, such as a needle. Should placement be erroneous subsequent x-rays and subsequent localizing needle placements will be required until adequate placement results. This provides localization of lesions or other areas of interest in human body parts in only one plane. In order to determine other parameters of location, such as depth, compression of the human body part must be released and the entire localization device placed in a different plane and the entire procedure as indicated above must be repeated. The release of the compressed human body part at this time changes all relationships as determined by the previous localization and may allow the localization needle to move with reference to the lesion or other area of interest in human body parts and change previously determined parameters such as location of the localization needle tip to the lesion or other area of interest in human body parts. Repositioning of localization device, movement of the subject human body part, and replacement of the localization device distorts all reference points producing inconsistent and unreliable localization of lesions or other areas of interest within human body parts.
In mammography, the localization devices used are placed in one plane to determine location and in a separate plane to determine depth. The human breast is compliant and flexible and in the replacement of the localization device for the separate plane view, the human breast returns to its normal configuration and location allowing the initial plane localization to become inaccurate.
In industry, similar non conforming localization apparatus is also used and with complaint flexible structures similar errors in accuracy result.
The conforming localization/biopsy and control apparatus of this invention applies the grid display directly to the subject human body part and fixes compliant and flexible human body parts in a box-like apparatus to conform the human body part to the shape of the box-like apparatus and thereby not allowing changes in the relationships of the lesion or other area of interest in human body parts to the grid display applied directly to the subject human body part during the obtaining of localization information in various planes by electromagnetic or visual means. A permeated calibrated control stylet is introduced into the permeated box-like apparatus and completely through subject human body part, lesion and/or other area of concern within human body parts and fixed at both sides of the box-like apparatus by locks to give a consistent indication of the depth and/or location of the lesion or other area of interest within human body parts in subsequent and various planes using electromagnetic or visual means. In comparison to presently available localizing devices, the conforming localizing/biopsy grid and control apparatus provides consistent and fixed relationships between all units of the composite producing accurate and consistently reliable localization of lesions or other areas of interest within human body parts.
In mammography, the standard localization devices are inflexible and require repositioning to establish relationships and parameters. This repositioning results in movement of structures internal to the breast thereby changing previously determined parameters and relationships in one plane while attempting to determine parameters and relationships in a different plane. The conforming biopsy grid and control apparatus of this invention fixes all relationships and parameters by applying a conforming, flat, pliable sheet with a grid display, visible to electromagnetic and visual means, variably numbered and lettered, to the outside of the human breast. The human breast with the conforming grid sheet applied is placed into an adjustable perforatee box-like apparatus conforming the human breast with applied conforming grid sheet to the shape of the confining adjustable perforated box-like apparatus, thereby, fixing all relationships and parameters of the composite and not allowing movement of the human breast. After noting the relationship of a lesion or other area of interest in human body parts by electromagnetic or visual means to the conforming grid, a perforated calibrated stylet visible to electromagnetic and visual means is placed through the composite in or adjacent the lesion or other area of concern within human body parts and exposes both of its ends which are locked in place on both sides of the adjustable perforated apparatus to prevent movement. X-rays are taken of the composite in various planes as needed to determine location and depth of a lesion or other area of concern in human body parts without concern for changes in relationships or parameters inherent in the movement of subject human body part in obtaining x-rays in various or subsequent planes. X-rays showing the human breast, conforming grid, box-like apparatus and fixed control stylet are used to place a localization device, such as a needle, accurately into or adjacent to a lesion or other area of interest in human body parts by inserting the needle through or adjacent to the permeated calibrated control stylet to the depth indicated on the x-ray view of the markings of the calibrated stylet at The depth of the lesion or other area of interest in human body parts. The localizing needle is secured by a barb near its tip and the composite of the conforming biopsy grid and control apparatus is removed for surgical biopsy or biopsy is performed using standard techniques while the composite is in place.
The localization requires the use of x-rays in two planes reducing radiation exposure. One plane for the insertion of the control stylet and one to determine depth of the lesion or other area of interest within human body parts.
In industrial uses, standard localization devices do not conform to the subject. The conforming localization/biopsy grid and control apparatus conform to subject outline and electromagnetic or visual means are used to determine location and depth of structures of concern within subject structure.